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European Foundation for the Study of Diabetes (EFSD) INTENSE Project: ImproviNg Treatment adhErence iN people with diabeteS mEllitus - Call for Tenders

Supported in part by an unrestricted educational grant from Servier

Deadline for submission of tenders: 15 January 2018

Background

The European Foundation for the Study of Diabetes (EFSD) was created by the European Association for the Study of Diabetes (EASD) to provide funding initiatives in all areas of diabetes research. The aims of EFSD are to encourage and support research in the field of diabetes, to rapidly diffuse acquired knowledge and to facilitate its application.

SERVIER is the leading French independent pharmaceutical company. Currently established in more than 140 countries, SERVIER has one of the world's highest ratios of investment in research and development. SERVIER’s strong commitment to innovative research underlines its mission to improve the quality of people’s lives by discovering and delivering therapeutic innovations to healthcare professionals, and to enable patients to feel better and live longer. Metabolic diseases and diabetes are amongst the most important therapeutic areas for SERVIER, together with cardiovascular diseases, oncology, and psychiatric diseases.

Process

In addition to its regular actions funding investigator-initiated studies in various fields of diabetes research, EFSD also supports specific projects for which it puts out a Call for Tenders. This competitive process, which is subject to peer review, is intended to identify the best academic team to carry out the described work.

Project and Research Focus

This EFSD project has been created to develop novel evidence-based approaches for the enhancement of patient adherence in type 2 diabetes therapy.

Introduction

Treatment outcomes in type 2 diabetes are largely dependent on the ability and willingness of the person with diabetes to undertake the necessary recommended daily self-care activities of a treatment plan mutually agreed with health professionals. These activities include a range of health behaviours, such as medication, healthy eating, being physically active, quitting smoking and, for some, self-monitoring of blood glucose. Patient adherence is the result of a complex interaction between patient-related factors, behaviour and communication skills of health professionals. and the health care system. Enabling people with diabetes to improve and sustain their adherence is recognized as a priority in diabetes care to help lower the personal and societal burden of the disease. Effective interventions are urgently needed and may involve organisational, medical, educational, behavioural and/or technological strategies, tailored to the (changing) needs of the individual with diabetes.

Objective of the project

The primary goal of the project is to identify strategies enabling people with type 2 diabetes, their carers and health care professionals to improve sustained adherence to the mutually agreed treatment plan.

Project outline

Given the nature of the project, the applicant team should include key diabetes stakeholders offering all necessary expertise. In order to achieve the overarching goal, the project should include but not necessarily be restricted to the following objectives:

Develop and validate new tools or implement existing methodology in the area of research (e.g. assessment tools, outcome measures, use of big data)

Evaluate biomedical, economic and patient reported outcomes, and their relationship to adherence

Project timeline – 3 years.

Budget - Not to exceed €500,000 Euros.

Mechanism of Call for Tenders and Review

EFSD issues this public Call for Tenders from clinical research groups based in the European region with the appropriate skills to undertake the project. Tenders will provide a detailed description of the work to be performed that will match or expand the outline summarised above and be designed to achieve all the major objectives of the INTENSE project.

All tenders will be evaluated by a peer review committee of independent experts in the field and established for this purpose by EFSD; the successful proposal will be selected by the Executive Committee of EASD on the recommendation of an EFSD Board convened for this purpose and guided by the rank order of scientific merit determined by the review committee. This Board, on advisement from the Review Committee, may on occasion and at its discretion recommend an award in a different amount from that requested, but which is considered more appropriate for the proposed studies.

One proposal will be funded in an amount not to exceed €500,000 Euros.

Tenders are invited from single non-profit institutions/organisations or groups of such entities from Europe and associated countries. The principal investigator and any co-investigators must be employed full-time at a non-profit institution and the study must be performed at their place of work.

Prior to any final decision on funding, and in order to offer applicants the opportunity to benefit from the review process, EFSD reserves the right to request revision to tenders in accordance with the recommendations of the Review Committee.

It is anticipated that a funding decision will be taken by April/May 2018.

Tenders may be subjected to pre-review (or triage) procedures. In this event, any tenders rejected at pre-review will not be subject to a complete scientific review. No written report will be provided for applications rejected at triage. The deadline for receipt of tenders is 15 January 2018.

All budgets are to be prepared in Euro. For countries in which the Euro is not the common currency, the exchange rate (between the Euro and the local currency in the country where the work is to be performed) used for calculating the Euro budget must be mentioned under "Budget Justification".

All tenders must be prepared on the official form and completed in strict accordance with the detailed instructions to be found on these forms. Tenders which do not comply with the instructions given in the form will not be considered for review.

Please send your tender as one complete PDF e-mail attachment to the following address before 12:00 noon (CET) on the deadline date: Foundation@easd.org

Review Considerations

Completed tenders will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate scientific committee convened by EFSD.

Relevance: To what extent does the proposal meet the primary goal and major objectives of the INTENSE project?

Approach: Are the conceptual framework, design, methods and analyses adequately developed, well integrated, and in keeping with those of the INTENSE project? Are they supported by preliminary data? Does the tender acknowledge potential problem areas and consider alternative tactics?

Innovation: Does the project employ novel concepts, approaches or methods?

Validation: Will the proposed objectives be validated in “real-life” settings?

The team: Is the team appropriately trained, experienced, and well suited to carry out this work? Is there full integration of all key diabetes stakeholders?

Environment: Does the scientific/clinical environment in which the work will be done contribute to the probability of success? Is advantage taken of unique features of the scientific environment and collaborative arrangements? Is there evidence of institutional support?

Budget: Is the requested budget appropriate for the proposed study?

Reporting Requirements and Approval of Funding

Annual progress reports will be required. These will be subject to assessment prior to the release of funding for the following year. A final report will be required within 3 months of the end of the project period. Investigators must provide EFSD with copies of papers accepted for publication, and must acknowledge the support in all written material by use of the phrase: "this work was part of the EFSD INTENSE project, supported in part by an unrestricted educational grant from Servier".

Schedule

Announcement:

August 2017

Tender Deadline:

15 January 2018

Anticipated Award:

April/May 2018

About us

The aims of the Foundation are to encourage and support groundbreaking diabetes research and to promote the next generation of leading diabetes researchers.